1st Information Day on the Development Safety Update Report (DSUR) Guidelines ICH E2F

Description

The new ICH guidelines E2F on the Development Safety Update Report (DSUR) has been signed off in August 2010 and will come into force in September 2011 in the European Economic Area (EEA). It is very likely that this report will replace the current Annual Safety Report on Clinical trials. This information day is intended to introduce the DSUR: its structure and content will be described and explained by the European experts who actively participate in the ICH E2F guidelines. Focus will be made on the practical issues based on the models for commercial and non commercial sponsors provided by the experts in charge of this topic in ICH. Finally some considerations will be discussed as to when and how this DSUR will be implemented in the EEA. A large place will be given to questions raised by the attendance during the panel discussion with all the speakers.